Guest Column12/24/08

Remember the importance of reading drug labels

Dec. 24, 2008

By Peter Pitts

For seniors, the holidays represent a special opportunity to spend time with children and grandchildren alike. Such family gatherings are also the perfect time to talk about serious issues with loved ones. Here’s one that’s especially relevant to seniors: the importance of reading drug labels.

Americans — and seniors in particular — have access to more cutting-edge pharmaceuticals than ever before. But medicines carry risks. Failing to pay attention to a drug’s label — by taking more than the recommended dosage or mixing with the wrong medicines — can lead to serious side effects.

Right now, only the Food and Drug Administration has the authority to approve drug labels. This helps consumers by ensuring that labels in all 50 states contain the same warnings about potential side effects and instructions for safe usage.

That may soon change. The Supreme Court is about to decide a landmark case about drug labels. The question before the Court is whether expert scientists at the FDA or local juries should have the final say regarding what’s written on a prescription drug’s warning label.

It all goes back to Diana Levine, a Vermont woman who went to a clinic because of a migraine. In the course of her treatment, a doctor’s aide administered the anti-nausea drug Phenergan. Tragically, the drug was improperly injected despite an explicit warning label. Levine ended up losing her arm.

Levine sued the physician, the assistant and the clinic. Each settled. But she also sued Wyeth, the company that produces Phenergan. A Vermont jury ruled that even though Phenergan’s label had been approved by the FDA, Wyeth should have prohibited the method of administration used in Levine’s treatment.

This put Wyeth in a pickle. By Vermont law, the company was now obligated to prohibit a particular method of drug delivery. Satisfying this requirement, though, would put the company at odds with the FDA.

If the Court rules against Wyeth, drugs could be required to have different labels in each state. And labels might end up reading like complex legal disclaimers.

Regardless of what the Supreme Court decides, this case should serve as a reminder for seniors about the importance of carefully reading and following the instructions on drug labels. There’s no better time than the holidays to make sure loved ones are doing just that.

Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.